MAUDE Adverse Event Report: MEDIVATORS DSD-201; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

Medivators clinical education specialist (ces) reported that while performing in-service training, a facility was using incorrect hookups and channel plugs for endoscopes being reprocessed in their dsd automated endoscope reprocessors.There is potential that endoscopes were not properly high-level disinfected, thus there is potential for patient cross-contamination.In-service training was provided for the facility's dsd-201 aers and dsd edge aers.Medivators ces reported while reprocessing endoscopes in their dsd-201 aers the facility was using rubber biopsy caps and olympus channel plug (maj-621) instead of the biopsy and channel plugs that come with the required hookup for the endoscopes.Medivators dsd-201 user manual warns users to use only medivators supplied hookups with the aer.The dsd hookup ifu also informs users the requirements for using appropriate biopsy and channel plugs.It was also reported that the facility was reprocessing their olympus suction cleaning adapter (maj-856) in their dsd edge aers which is not validated to be reprocessed in the aer.Medivators ces referred the facility to the olympus ifu for proper reprocessing instructions of the maj-856 suction cleaning adapter.It was also reported that the facility is using dsd hookups with their ruhof scopevalet cleaning and flushing device.Medivators cannot confirm that the dsd hookups are validated for use with the ruhof scopevalet device.Medivators ces informed the facility's management of these findings and they reported they would review and correct their processes.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.

Event Description

Medivators clinical education specialist reported that while performing in-service training, a facility was using incorrect hookups and channel plugs for endoscopes being reprocessed in their dsd automated endoscope reprocessors.There is potential that endoscopes were not properly high-level disinfected, thus there is potential for patient cross-contamination.

• Brand Name: DSD-201
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 7868434
• MDR Text Key: 119951934
• Report Number: 2150060-2018-00061
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other